Subcutaneous infliximab in children with IBD: exposure doubled after the switch, off-label

Design

Systematic review and single-arm meta-analysis of five observational cohorts (PROSPERO registered)

Population

162 children and adolescents with inflammatory bowel disease; median follow-up about 6 months

Primary outcome

Treatment persistence, clinical remission, drug concentration, immunogenicity and safety

Effect

Persistence 89.8% (95% CI 72.6 to 99.0); remission 90.2% (61.3 to 100); mean infliximab 11.4 to 21.9 micrograms per mL; new antidrug antibodies 0.7%

Subcutaneous infliximab is licensed for maintenance only in adults with inflammatory bowel disease, and paediatric data sit in small cohorts. This first pooled analysis restricted to children included five observational cohorts and case series with 162 children (70% Crohn disease, 28% ulcerative colitis), switched from intravenous infliximab or started de novo. Median follow-up was about 6 months.

Persistence on treatment was 89.8% (95% CI 72.6 to 99.0) and clinical remission near 6 months was 90.2% (61.3 to 100). Mean serum infliximab concentration roughly doubled after the switch, from 11.4 to 21.9 micrograms per mL, and new antidrug antibodies were rare (0.7%). Clinical relapse occurred in 4.8%, serious adverse events in 1.5% and injection-site reactions in 11.0%. Certainty of evidence was low to very low.

Almost all children switched while already in remission, so the data cannot show that starting subcutaneously induces remission. The pooled intervals are wide, and use in children is off-label. Treatment decisions belong with a paediatric gastroenterology team using therapeutic drug monitoring.

• Treat use in children as off-label and decide it in a paediatric gastroenterology team.
• Measure trough infliximab and antibodies before and after any switch, where assays are available.
• Switch only children who are in remission; the data do not support starting de novo.
• Watch for injection-site reactions and relapse in the first months after the switch.
• Check the product's availability and cost locally before planning a change.

Why it matters

It suggests the exposure benefits seen in adults may carry over to children, which matters for dosing intervals and monitoring.

Don't overread it

The evidence is low to very low certainty from small uncontrolled cohorts; it does not establish induction of remission or superiority over intravenous dosing.

The statistics, in plain English

Pooled proportions near 90% look reassuring, but they come from single-arm cohorts without a comparison group, and the confidence intervals (for example 61.3 to 100 for remission) are wide. Higher serum concentrations are a pharmacokinetic finding, and they do not by themselves show better outcomes.

Read the rest in the app

You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.

Get Daily Doctor — free

Scan to keep reading on your phone. No account needed to start.